UCSF and USDA agree to settlement

By Corinna Kaarlela

UCSF said today that it has reached a settlement with the United States Department of Agriculture regarding an animal welfare complaint that was initially served last fall.

The settlement was filed as a Consent Decision and was signed by both parties.  It was finalized September 23 in Washington, DC.

Under the terms of the Decision, UCSF does not admit to any of the allegations in the complaint, except that USDA has jurisdiction in this matter; agrees to follow all rules and regulations of the Animal Welfare Act; and agrees to pay a civil penalty of $92,500.

Issued in August 2004, the complaint alleged that UCSF violated the Animal Welfare Act through its animal research program. UCSF filed a response to USDA a few weeks later stating that it disagreed with many of the allegations and citing reasons for the disagreements. The University and USDA subsequently negotiated this settlement.

The animal research program is one part of the University’s total biomedical research enterprise, which supports the UCSF mission of saving lives and improving health.

UCSF officials emphasized that they consider animal research to be critical for making progress in some aspects of biomedical science, and they are committed to the highest standards for the care and use of animals in this work. “High-quality science involving animals and high-quality animal care are inseparable,” said Ara Tahmassian, PhD, associate vice chancellor, UCSF Office of Research.

He noted that animal research is a highly regulated enterprise and that UCSF is subject to all applicable federal and state laws and regulations. This includes regulation by the U.S. Public Health Service Policy on Humane Care and Use of Laboratory Animals, the National Research Council’s Guide for the Care and Use of Laboratory Animals, and the USDA Animal Welfare Act regulations regarding the care and use of animals in a research setting, as well as University of California policies. 

Before any research study involving animals even begins at UCSF, the protocol undergoes a rigorous review for scientific merit by the outside funding agencies, such as the National Institutes of Health and National Science Foundation.

Once this merit is established, every proposed research study involving animals undergoes an in-depth scientific and ethical review through the University’s Institutional Animal Care and Use Committee (IACUC). IACUC reviews the proposed protocol to ensure that the use of animals is justified, that the animals will receive the highest standards of care, and that personnel are properly trained to carry out the research.

Over the last five years, UCSF has invested nearly $100 million to build and equip new facilities for the housing and care of animals.  This includes a program dedicated to enriching the animals’ environment through the use of exercise, housing groups and interactions with people.  Animals are monitored seven days a week by animal care staff.

In addition, UCSF is fully accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC), an independent, non-profit organization that inspects and evaluates animal research programs and facilities. This voluntary accreditation is considered the gold standard both by advocates and critics of animal research.  It is recognized as demanding the highest ethical standards for the care and study of animals.

Medical advances resulting from animal studies at UCSF include life-saving treatments for premature infants, fetal intervention procedures to correct life-threatening disorders before birth, techniques to correct certain heart disorders without open-heart surgery, and insight into the mechanisms of HIV/AIDS and neurodegenerative diseases such as Alzheimer’s and Parkinson’s.

Animal research has paved the way for nearly every medical advance of the last century, such as development of vaccines to prevent polio, measles and rubella and development of penicillin and other antibiotics to treat bacterial infections. Under current Food and Drug Administration requirements, all medical devices and drugs must be tested for safety and efficacy in animals before they can go to human trials.